Ambu A/S

CSE:AMBU B

Earnings Call Transcript 2022-Q1

[Nicolai Thomsen]

Good morning, everyone, and welcome to the conference call for Ambu's Q1 results. I am Nicolai Thomsen from the Investor Relations team. I'm here with our CEO, Juan Jose Gonzalez; our CFO, Michael Hojgaard; and Bassel Rifai, our Chief Marketing Officer. Today's presentation can be found on our home page and there will be a Q&A session at the end of the call. [Operator Instructions] And with that very brief introduction, I'm very happy to hand over the word to our CEO, Juan Jose Gonzalez.

[Juan Jose Gonzalez, CEO & Member of Executive Board]

Thank you, Nicolai, and hello, everyone. We are going to spend a few minutes talking about the company, the development in the market, our performance, the progress in terms of our innovation, and then we will open for Q&A. So let's start with the key messages for this call.First of all, the driver for the creation of a single-use endoscopy market continues to accelerate, where it is the focus on contamination, where it is the pressure in terms of labor shortage. All that is highlighting the challenges with the reusable endoscopy model and the benefits of single-use.In our Q1, we are reporting very strong performance. Adjusted by the NHS safety stock order, the company grew 13% driven by Visualization, growing 26% in revenue and 46% in volume. ENT and cysto continue to be the #1 growth engine for the company. And I will spend a few minutes talking about the rapid penetration of ENT and cysto. And we are also advancing our entrance into GI. And Bassel will talk about the progress with our Duo 1.5 and with our gastro launch.There is volatility in the market, driven by Omicron. And I think many med tech companies have talked about the impact on elective procedures and labor shortage. It's unclear in terms of how this will unfold. We see this as a short-term impact, and it is on the back of that, that we are reflecting this higher volatility in our guidance.And in terms of our innovation, what is going to drive the continued rapid growth of the company, we are actually confirming our ability to bring all of our launches by 2022, '23, including major launches in 2022, where it is our entrance into the aScope 5 in the bronco suite or the launch of our Duo 2.0 that will give us technical superiority, whether it is our entrance into gastro or into colon or ureteroscope or our cysto high definition. The company will emerge as the leading single-use endoscope player.Now let me just spend just a brief moments to introduce Ambu to any new investors in the call. And just for context, single-use endoscopy is one with the most attractive med tech market. The market is expected to grow from $500 million to $2.5 billion by 2025. And the 3 main drivers of endoscopy are an increased focus on infection control, an increased need for workflow and efficiency, which is further highlighted on the back of the labor shortage and rapid technology advancement. This is sensors. This is image-enhancement software. So basically, every generation of single-use scopes is more powerful than the previous one, is more competitive relative to the reusable endoscope and had a benefit around infection control and efficiency.Now within this market, Ambu is the #1 player in single-use endoscopy. Over the last 3 years, the revenue CAGR for the company is 16%, driven by a Visualization business growing 34%. Actually, in the last 3 years, we have tripled our volume and we have increased our gross margin in the last 5 years by 8 points, showing the profitability potential of this model.And our strategy is very clear. Number one, we want to build the most comprehensive and technologically advanced portfolio by leveraging our R&D modular engine. Number two, we are introducing these products with a pricing that enables the rapid transition from reusable to single-use. And we're able to do that because of our high-scale, low-cost manufacturing setup. And finally, we are maximizing our first-mover advantage by rapidly scaling our commercial infrastructure. So we are in a position to effectively commercialize all of these new products. And it is on the back of this strategy that we will emerge in 2025 as a clear leader in single-use endoscopy.Now let's talk about the recent developments in the market, and there are two things. One is the reports around endoscopy-related contamination from reusables continue to increase year-over-year. And if you look at this trend, if we pick a year, 2016, 709 reports in the U.S. By 2021, 5 years later, it's more than 3x the number of reports. And going forward, we expect this to increase as the FDA is asking for more detailed reporting of this level of incident. And the issue with this is that regulators and reusable endoscopy players are responding by setting more complex, more longer, more labor-intensive reprocessing guidelines creating more burden in the hospitals. This is an issue because at the same time, we are facing a labor shortage challenge where it is the American North Association indicating that there is a national crisis where it is 24% of U.S. hospitals reporting critical staffing shortages.There is basically no ability to be able to do more endoscopy procedures, and this market is growing year-over-year with the reprocessing guidelines that are becoming more complex while having this labor shortages. And all of these environment is highlighting the benefits of single-use endoscopy and why single-use endoscopy is a more efficient and effective way to do endoscopies in the future. And it is on the back of this that we have achieved a very strong performance in Q1. Basically, as I said before, adjusted for the NHS safety stock order in Q1 last year, our organic Visualization revenue growth was 26% and our volume growth was 46%. I mean, this is a record 418,000 units sold this year. If you look at our Q1 2021, '22 units sold, we have actually more than doubled in 2 years. And as a result, our Visualization sales as a percentage of the company, it has increased around 35% 3 years ago to 55% this year.Now if you look at the main driver for this volume growth, it is our ENT and cystoscopy offering. We continue to see a very strong traction of these two products, and they are actually growing double digits over previous quarters for the last 6 quarters. Actually, in Q1, our aScope Cysto have already generated more than 50% of what we sold in the full year last year, reflecting the rapid transition to single-use. We are expecting this year that urology and ENT combined are going to exceed the 700,000 units sold. This is very important because this is not a segment driven by contamination. This success is driven by the acknowledgment that with the technology of these products and the significant benefits in terms of workflow and efficiency, single-use ENT and cystoscopy is the smart way to move forward. And even with all the challenges that we are seeing in terms of labor shortage, we see that the more challenged, the more likely the hospital to rely on single-use endoscopy to be able to manage their hospital capacity.Now many companies have talked about the impact of Omicron. I think over the last few weeks, we have seen reports from all the major hospital, med tech companies talking about the impact of Omicron on their business. Let me just give you a perspective in terms of how we see this impact in Ambu. First of all, we see the impact from Omicron started in mid-December last year and is expected to have a further negative impact in Q2 and Q3. We expect it to be more of a Q2 impact. And in Q3, it will start coming out. But overall, we see a negative impact in both quarters.In the short term, Omicron has a following negative impact. First of all, it is less severe. So we generate less extra demand in bronchoscopy than previous variants. It drives a contraction of elective procedures due to the hospital staff shortages, driven by infection and self-isolation and limit access to hospitals to demonstrate new products, like in the case of our aScope Duo 1.5. As a result, we expect our Visualization sales growth to be impacted in Q2 and Q3 this year. And in spite of the Omicron disruption, we still expect our core business, our PMD and Anaesthesia, to deliver double-digit growth.Now this is the impact of Omicron in the short term. Of course, at the same time as Omicron is impacting the elective market, it also further highlight that in the midst of labor shortage challenges, single-use represents the best alternative. So we actually see a benefit in terms of penetration of single-use endoscopy over the medium term. We will emerge on this Omicron -- from this Omicron variant with a higher level of penetration than before.Now I just spoke about the development in the market. I talked about our performance, the rapid growth of ENT and cysto, Omicron as a short-term factor that is driving volatility. Let me pass it to Bassel Rifai, who will talk about our entrance into GI.

[Bassel Rifai, SVP & Chief Marketing Officer]

Thank you. And as Juan Jose shared, our goal is to be the #1 player in single-use endoscopy. And a key part of that is to drive leadership in GI, which will be the largest single-use market in 2025.Now we have an aggressive agenda in GI, which began with Duo. It's going to continue with gastro follow a Duo 2.0 Colon and Cholangio, so that we build a full range of GI single-use scopes in our portfolio. And today, I'm going to focus on Duo 1.5 and on gastro.So as we advance our Duo 1.5 launch, there are two key messages to take out from today. Number one is that this is going to be one of the largest single-use endoscopy markets in 2025 because all the drivers of market creation are getting stronger and stronger. Reimbursement for single-use is expanding. It began with Medicare outpatients and then expanded to inpatients. And now even over the past few months, we're seeing many more major private insurers providing a special payment for hospitals for doing single-use Duo. And at the same time, reusable systems are continuing to have more problems. So just over the past few months, we've seen a Class II recall for the Olympus 180 system. We've seen a safety warning for the Olympus 190 system. And that just shows the complexity, and it shows the shortcomings of reusable Duo duodenoscope.And key message number two is that within that large single-use market, just as we're the market leaders in pulmonology and ENT and urology, we believe that we will be the market leaders in Duo. Technically, we have a scope that is very competitive. We just finished our 150-patient trial with 8 of the leading ERCP centers in the U.S., places like Indiana University, which is the highest volume center in the U.S.; the Mayo Clinic and Baylor. And across those 150 patients, we're seeing a more than 97% success rate. And that compares very favorably versus the competitor scope, which published a success rate of less than 91%.So technically, we have a scope that's very competitive. And then from an economic point of view, we have a more favorable price point. And we believe that these two combined are going to give us a higher win rate. And based on our experience so far in head-to-head trials, we are confident that we're going to be #1 globally and especially outside the U.S., where pricing is an even more important decision factor.So on Duo 1.5, although we're seeing the near-term disruption from Omicron in terms of hospital access, overall, we're very pleased and very encouraged with a high level of interest and the outlook for the product.Now we've always said that Duo is going to be one of the largest segments in 2025. And the next question is, how big can gastroscopy be? So let's talk about gastro. First of all, gastro is one of the largest endoscopy segments. It's bigger than pulmonology, ENT, cysto and Duo combined. So it's a very large market. It's also a very diverse market. So gastros can be performed in the Endosuites by GI doctors, but they can also be performed in the operating room by a bariatric and foregut surgeons. They can be performed in intensive care when patients are too frail to move from intensive care to the Endosuite. They can be performed in the emergency room. So there are millions of gastroscopies that are taking place, both inside and outside the GI department. And then the question is, are there conditions in gastro similar to what drove single-use adoption in cysto and ENT and bronc? And we believe that the conditions are similar.And there are three main challenges with reusable gastroscopy systems. First of all is lack of availability. So there is a need to do gastroscopies across these multiple care settings, while reusable equipment is mainly available in GI departments. That makes it difficult outside of GI departments because you need to move a tower or invest in having specific tower, which is not always possible. And when we speak with doctors, they talk about the challenges of operating across multiple sites of care. They described the cumbersome process of moving bulky towers throughout the hospital. And they show that, that's why that more than 2 million procedures are delayed every year because of scope availability.The second challenge is the workflow burden and there's a need to do more and more gastroscopies, but the complexity of the current reprocessing model simply does not allow that, especially with the staff shortages that we're seeing today. And again, when we speak with doctors, they talk about the burden these volumes are putting on nurses and other staff and the impact that has on morale and burnout and staff turnover. And the U.K. is a great example where as an NHS system, they want to have less than 1% of patients waiting more than 6 weeks for gastroscopy. Before COVID started just purely because of staffing shortages, that number was at 10%. And today, that number is over 40%. So that means there's a significant waiting line that will not be addressed through reusable endoscopy. And that situation in the U.K. is the same as the situation we're seeing in Germany, in France, in the U.S., in Japan, in most of our key markets.So the way these first two points lack of availability and workload burden. Those are exactly the drivers that led to the option of single-use and ENT and cysto. And then on top of that, you have a contamination risk with a more than 500% increase in cross-contamination FDA complaints just in the past 5 years.So those are the challenges with reusables. And of course, single-use gastro allows you to address all of them. It allows you to perform gastroscopies at all times in any setting with low capital investment. It eliminates 100% of reprocessing. And it's 100% sterile, which by the way, for areas like the operating room, which is a sterile environment, is important. And single-use is a better solution than taking a nonsterile reusable into that site of care.So those are the conditions that support single-use penetration in gastroscopy. Now let's talk about our single-use gastro system, which we're excited to share. It was just approved last week. Now the overall message here, the most important thing to know is that this is by far the most advanced technology we've introduced both in terms of scope and in terms of display platform.Now in terms of the aScope gastro, this product was specifically designed to target half of total gastroscopies. It has a camera sensor that's 4x more powerful in terms of image resolution than our aScope 4. And the feedback from doctors is that it is so similar that they can take this with practically no learning curve and put it into profits immediately. They share that the mechanical performance and maneuverability is on par with reusables. And they even share that some features like bending performance is superior to reusables, especially compared to the reusable scopes that they work with day-to-day, the scopes that have degraded over time. And we're going to be launching this scope with a global ASP of $350, and that means that we're going to have an economic value proposition to go to the product performance that supports transitioning large volumes of procedures to single-use.Now in terms of our display and processor platform, we designed the aBox 2 to be at the center of our ecosystem for the future. It has a full HD image with advanced image processing, and it has increased processing power versus aView 2. And that, combined with our new camera sensor, will set a new benchmark in terms of image performance. It had a touchscreen display, which doctors describe as intuitive and like an iPad. And of course, the compact design, combined with a low capital investment and a global ASP of $7,500 makes it more easy to adopt in multiple sites of care and unlock those volumes.So with a very large and diverse market, with the conditions that support the transition to single-use, with the most advanced technology we've introduced and with all the positive feedback we've gotten these past few months from dozens of KOLs in different markets, we're excited about what single-use gastro can do. And we're proud of every one at Ambu who helped to bring this important innovation to health systems, to doctors and to patients. And we're confident that with both Duo 1.5 and gastro are poised to be important growth engines for the company as we expand our presence in GI.And now to share more on our broader innovation pipeline beyond GI, I'm going to hand it back to Juan Jose.

[Juan Jose Gonzalez, CEO & Member of Executive Board]

Thank you very much, Bassel. And I have to say aScope Gastro is just one example of many in terms of what we are planning to do with single-use endoscopy, bringing next generations of more technologically advanced products at affordable prices to drive a very rapid transition from reusable to single-use.Our strategy is to build the most advanced and comprehensive ecosystem in single-use endoscopy. And basically, we are building a set of -- we're building a modular engine that have proprietary technology around modular camera and sensor platforms, image processing and ergonomics and maneuverability. Actually, if you look at our patents behind these technologies, we have filed in the last 2 years more that in the previous decade combined. There is significant focus on building proprietary technology to create this ecosystem. And on the right-hand side is an ecosystem today and it's starting to look more powerful, certainly more powerful than 3 years ago. The most important thing is how it is ecosystem going to look like.Now we are on track to launch our rich pipeline by 2022, '23. We have, in this calendar year, very important launches. The next important launch is going to be our aScope 5 Broncho that will allow us to enter into the Broncho suite. It has the same advanced technology that Bassel described in terms of our aScope Gastro. But it's not only going to be that, we will also launch what we will consider a technologically superior view laryngoscope that will be connected with our entire pulmonology offering. And it's not only that, we will enter into ureteroscopy. The number one reason why ureteroscopy is not 100% single-use is pricing. It's an endoscopy procedure where the reusable scopes break offering is very expensive and very complex. And we are going to bring a product, which is competitive from a technology point of view, but at a fraction of a price. And on the back of that, we will drive significant penetration, also leveraging our already presence with our cystoscope.And in cystoscopy, we are growing very rapidly. And on top of that, we will introduce a cysto high definition, which will further accelerate our growth.And in terms of GI, this year, it's not just Duo 1.5, it's not just our scope gastro, but it is also the introduction of our aScope Duo 2.0, which will consolidate our technical superiority against competition. And on top of that, it's going to be our colonoscope.These are just some of the most important launches that we have for the year 2022. They are not all of them, but they are the most important ones. They will be the ones that we believe will drive significant growth going forward. There will always be some volatility in terms of approval timings and so forth, but you can rely in terms of these launches coming in this calendar year and our entire pipeline by 2022, '23.And with that, I pass it to Michael Hojgaard, who will talk about our financials.

[Michael Hojgaard]

Thank you, Juan Jose. I will take you through the financial highlights for the quarter. And in the end, I will elaborate a little bit on our revised guidance and the assumptions that we have put behind.Let's dial out with the financial results for the quarter. Organic revenue growth in the first quarter came in at minus 1 percentage and was in line with expectations following the high growth performance in the first quarter of 2021. If we adjust for the NHS safety stock orders of bronchoscopes in Q1 last year, the organic growth in the first quarter is 13% with Visualization at 26% growth. Combined for all regions, we sold 419,000 endoscope units, which correspond to a volume growth of 13%. Again, if we adjust for the NHS order, the volume growth is 46%.We are very satisfied that we've been able to pick up the revenue from an extraordinary quarter last year and, at the same time, further growth number of units sold. The growth in units sold reflects the rapid expansion of our single-use endoscopy portfolio, which now covers multiple segments beyond pulmonology.Our gross margin ended at 61.5%, and the decline from Q1 last year is driven by lower revenue from higher-margin products within Visualization and an increased cost levels, including building capacity in Mexico. Finally, EBIT earnings ended at DKK 40 million with a margin of 3.9%.The total Visualization growth rate of minus 2% was significantly influenced by last year's high comparable. But when we look at the 3-year perspective, the organic revenue compound annual growth rate for Visualization is 34%. All of our geographies present 3-year revenue CAGR for Visualization well above 25%, which reflects a healthy geographical split of the demand for single-use endoscopy. Overall, Visualization now makes up 55% of the total business in the first quarter, which is 20 percentage points more than just 3 years ago.The performance contributed by Anaesthesia and PMD is more blur. We see volatility in elective procedure activity, a disruptive supply chain environment, and we therefore exit the first quarter with bag orders in both Anaesthesia and PMD.Looking at the geographical distribution, North America reported an organic growth of 18%. Growth in Visualization came out strong with 34% organic growth, but Anaesthesia was impacted by lack of supply while PMD, on the other hand, was positively impacted by a return to near pre-COVID revenue levels. The revenue in Europe declined organically with 16%. The decline was as expected since the NHS orders were nonrecurring. And if we adjust for these orders, the organic growth is 10%. For Visualization, organic growth for the quarter came in at negative minus 23%, but plus 22% when adjusted for the NHS orders. Like in the U.S., we see a nice pickup in PMD on top of a depressed base, and we see negative growth in Anaesthesia, partly due to a high comparable.Rest of World posted organic growth of nil. That's a flat development with Visualization at 11%, where we continue to see very positive results from our single-use endoscopy portfolio in key markets. Anaesthesia and PMD were negatively impacted due to back orders and downturn in elective procedures.Now allow me to comment on some of the relevant financials we have in the quarter. Our gross margin in Q1 declined with approximately 4 percentage points, driven by sales mix and increased production costs. The mix had a negative effect on Q1 revenue due to last year's higher relative share of Bronch within Visualization caused by the NHS safety stock orders. We estimate this impact to equal a decline of the gross margin of approximately 2 percentage points.Our production costs have increased by DKK 46 million, corresponding to a 13% increase since last year. The cost of scaling up the factory in Mexico, paired with increased prices on raw materials, have had a further negative effect on this quarter's gross margin of approximately 2 percentage points. Combined, these two factors equal the decline of approximately 4 percentage points in the gross margin.The global supply chain continues to be disrupted, and this drives a need for continuous use of air freight. This, paired with the fact that freight rates have continued to be extraordinary high, have caused a total additional spend on freight to be roughly DKK 35 million in the quarter, which equals approximately 3.4 percentage points of the quarter's EBIT margin.Finally, let me provide some color on the revised outlook we announced this morning. The impact from the Omicron variant is expected to continue to create volatility into our second and third quarter this financial year and will, therefore, have a short-term negative impact on our business performance. The impact is driven by lower elective procedure activity as hospital have staff face shortages, reduced access to hospitals to demonstrate and to launch our new products and the fact that the variants is not driving an extraordinary demand for single-use bronchoscopes like previous variants did. As a result, we have revised the outlook for organic growth from previously 15% to 19% to now to be equal to or higher than 15%. And the outlook for EBIT margin from previous 7% to 9% to now be equal or higher than 7%.With that, I will hand back the word to you, Juan Jose.

[Juan Jose Gonzalez, CEO & Member of Executive Board]

Thank you very much, Michael. I mean, we are growing Ambu as one of the highest growth, most innovative med tech companies. We are doing it in the midst of significant disruption. Whether it is Omicron, whether it is supply chain, whether it is inflation, it's an environment with significant volatility. But we are 100% focused on the execution of our strategy. The single-use endoscopy market will emerge as one of the largest new markets in med tech. And within that environment and on the back of our innovation, on the back of our R&D model arranging our high-scale low-cost manufacturing, we will emerge as a clear leader in single-use endoscopy.Thank you very much, and let's open for Q&A.

[Operator]

[Operator Instructions] The first question is from Thomas Bowers, Danske Bank.

[Thomas Schultz Bowers, Analyst]

A couple of questions. I'll try to limit myself to two here. So first of all, just on the margin development. So obviously, a very back-end loaded year as you also have highlighted in -- back in November. But can you maybe just share a little bit of color on how we should see these levels in H2 and maybe Q4 flow into the next year because as you say, a quite large spread in the consensus number. So I think it would be much appreciated in the market to understand when we actually should expect this, you would say, subdued levels on earnings to go back to at least sort of historic levels for what you were at the mid-teens with the Core division?And then maybe also give us a bit of understanding on the risk to the balance sheet here and -- with, of course, at the debt ratio and also the subdued cash flow. So how we should sort of picture that in the next 12 months' time plus maybe? And then just to understand your guidance revisions here for this fiscal year. So you're still -- well, actually, you're guiding now double-digit growth in Core. And so I'm not really sure you see much impact despite the extended order backlog here. And then on ENT and cysto, you guide above 700,000 units. I sort of read this as a better than expected. So is this mainly driven by duodeno uncertainties and maybe also sort of a perfect storm here with lower broncho impact on COVID and the limitations to lift the procedures? And then if we could [indiscernible] half a question just on the duodeno trial, can you just comment on the complexity levels in this clinical trial? So does this reflect, you say, the real-life setting with, you could say, 1/3 proportion of Level 3 and Level 4 ERCP?

[Juan Jose Gonzalez, CEO & Member of Executive Board]

Thank you very much, Thomas. I think I counted four questions, but I think they are all relevant. So let's go through each of them. Let's start with the last one. Our Duo clinical trial was done across 8 sites, which include the largest and most prestigious ERCP centers in the United States. And they actually cover all levels of complexity. Actually -- and you will see this when we present the DDW.When you look at 150 procedures done with our Duo 1.5, the mix in terms of level of complexity is actually higher than what you see in the overall market. So it's something we pressure the scope against the most complex procedures. And what is very encouraging, of course, is the better performance to our competitor 200-patient clinical study. That basically shows that you have a pro that is better able to reach a successful completion with a procedure with much better economics.Now in terms of the guidance. So we guide for double-digit growth in Core. A lot of our growth in Core is also driven by the fact that last year, our performance was depressed and the backlog that we carried from last year into this year. We are guiding for a volume for ENT and cysto combined of over [ 700,000% ], but what we are doing is we are reflecting the uncertainty of Omicron in terms of elective procedures, how much will be -- will they be depressed, for how long? Of course, the shorter it is, the better for us. The longer it is, the worse for us. And the impact in terms of our ability to showcase our products, which we also consider in terms of short-term challenge.I think we're going to get more clarity by the end of Q2, and we'll be able to get a better sense in terms of what is a real impact for Omicron. But at this point, we consider prudent to have that guidance.Now in terms of margin development. However it is your forecast for Ambu quarter-over-quarter, by quarter 4, we are going to have a high level of sales and a high level of profitability in a year where our profitability will remain depressed because of the abnormally higher logistic costs and raw material inflation. Two of which we expect to reduce going forward and to further capture efficiencies from our Mexico plant, which will reduce the need to air freight from Asia Pacific to the U.S. and that will reduce the need of inventory tied to our sea pipeline.That basically means that going forward, if we move into the following year and the following one, the company will continue to grow rapidly on the back of our existing products and innovation. And we will see the leverage from that in terms of our commercial infrastructure, and we will get this one-off benefits correctly. And it is on that basis that we always say that Ambu has a potential to have attractive profitability levels. We cannot give you a guidance right now in terms of what will it be, but there is a clear path towards an improvement in terms of our EBIT.I leave the questions around the risk of the balance sheet to Michael. And I don't know if you want to comment anything more in terms of the margin development, but I think...

[Michael Hojgaard]

No, I think you said it well, Juan Jose. And I think we have historically proven that our model is highly scalable. So I'll leave that with the operating margin.But Thomas, with respect to the balance sheet, I think also this call here, we have clearly demonstrated that we have a very high innovation capacity, and you have seen pictures of the most recent products that have been cleared. So my point is that everything we are doing is done in a very controlled manner. And yes, you have a point that we are spending more than DKK 160 million of cash in this quarter. But of course, we have taken through actions in order to secure that. The plan we have laid in front of us, we're able to finance. So I think that's probably the best answer I can give to that question.

[Operator]

The next question is from Alexander Berglund, Bank of America.

[Alexander Berglund, Analyst]

First, just want to clarify a bit on the average selling prices. Is this solely a mix effect that more ENT and urology? Or is there anything on pricing here or anything on potential kind of volume discounts, so higher volume discounts? So that's my first question.The second one, if I can try just to focus a little bit on the balance sheet again, given the relatively high leverage. Can you help us anything about how to think about kind of cash movements in the sense of kind of working capital to sales, for example, is quite high now. Do you expect to get any kind of working capital to release towards the end of the year? And then also, if you can give us any kind of sense of how to think about cash R&D spend throughout the remaining quarters given kind of you capitalized on the balance sheet? So that would be very helpful.

[Juan Jose Gonzalez, CEO & Member of Executive Board]

All right, Alex. Thank you very much. So let me first answer your question regarding ASP. And this is 100% driven by our mix effect. We have a strong performance in Broncho, and we are growing ENT and cysto very rapidly. I mean, the growth in these two platforms is really remarkable. And I have to say much faster than what we ever anticipated when we first introduced these products. There is no volume discounts. There is no need to do any volume discounts because we have the most competitive prices in every segment where we participate.Now in terms of our balance sheet, if you look at our working capital, a lot is also tied to inventory. And of course, we expect our situation in terms of inventory to improve as the time of delivery from Asia to the U.S. go back to normal levels. Right now, it's twice longer than what it used to be. That is going to help us to free up inventory. Mexico is also going to help us to be able to do that. So that, I will say, is going to be a very important improvement in terms of our working capital.Michael, I don't know if you want to comment anything else in terms of our cash R&D spend?

[Michael Hojgaard]

I think we have been very open about that innovation is at the core of our strategy. So we are -- yes, we are spending a lot of resources within innovation, and we have a very rich pipeline of products to be launched. I think the most important, Alex, is that we are very loyal to our accounting policies. So we are diligent in the way that we register our innovation products -- projects. And the spend goes into the projects and is being released for amortization upon the time where we receive the FDA approval of the product. So as from this quarter, you will see or you will not see, but we are going to start amortizing the impact from the gastroscope and so forth. So there's really no change into that.

[Operator]

The next question is from Christian Ryom, Nordea Markets.

[Christian Sørup Ryom, Senior Analyst]

So the uptake trend for ENT and cysto clearly continues to look very, very impressive. The flip side of that is that, at least as far as I can gauge, bronchoscope sales appears to have been stagnating or down over the last few quarters, say, quarter-over-quarter. What is the explanation behind that? Is that purely COVID dynamics that you'd attribute that to? That's my first question. And then my second question is also related to ENT and cysto. So given this very, very impressive momentum, are you transferring increased resources to these two products? And if so, at what expense are you doing that?

[Juan Jose Gonzalez, CEO & Member of Executive Board]

Sure. Christian, thank you, and excellent questions. So if we look at our Broncho business, you basically have 2 dynamics. One is 2022 is going to be more of a normalization year after a couple of years where the overall ICU market was very large on the back of the COVID pandemic and last year on the Delta variant.The second thing is that our penetration of this market continues to increase year-over-year. And that's why you see this year as if there is a slowdown in our growth. And actually, we expect our Bronchoscopy business in the following years to continue to go at an accelerated rate. And that's even before we introduced our aScope 5 into the Broncho suite. So there is a market last year, which is very large. This market is smaller, and now we are driving more penetration.Now if you look at ENT and cysto, what we are doing is we are not reallocating resources from other areas. We have invested in setting dedicated urology resources, both in the U.S., in Europe and Asia Pacific to drive a more rapid acceleration. And our performance on ENT and cysto in Q1 does not reflect the benefit of this investment in dedicated commercial infrastructure. We actually expect to see the benefits of that in quarter 2, quarter 3 and quarter 4.

[Operator]

The next question is from [ Richard Anderson ], Handelsbanken.

[Unknown Analyst]

So first one on the gross margin. Should we still expect the gross margin to be slightly below last year level as per previous guidance?And secondly, can you give some flavor on the current commercial infrastructure in GI? Will you need a larger footprint to make an impact already this year for the aScope Gastro? And should we expect additional studies with aScope Gastro needed to drive meaningful demand here?

[Juan Jose Gonzalez, CEO & Member of Executive Board]

Sure. In terms of commercial infrastructure for GI, we have the infrastructure that we need to commercialize effectively our Duo 1.5 and to start the commercialization of gastro. So we don't see the need of more commercial infrastructure. In terms of clinical, we don't expect to share any clinical results in terms of gastro this year. We have a clinical program across our endoscopy area. And as we make the result public, we will share them. In terms of gross margin, I think we talked about in our guidance that our gross margin was going to be below last year, and I think Michael talked about the drivers for our performance in Q1, starting with Mexico, with raw materials and with our mix. What is important to know is that when you look at our overall pipeline of launches, the overall gross margin should be assumed to be constant, which basically means that, as we grow Visualization, the gross margin for the overall company will continue to increase. And on top of that, we will have a benefit from moving away from that short -- part of a short-term impact in terms of raw materials. And of course, as we move into the next year, we will see more leverage from our Mexico investment. So overall, that -- those are some of the considerations as we project our gross margin.

[Operator]

The next question is from Niels Leth, Carnegie.

[Niels Granholm-Leth]

A couple of questions on financials. So could you talk about your expected cash burn for the next few quarters? And in continuation of this, could you talk about if you're happy with your current net debt-to-EBITDA ratio of 2.7x?

[Michael Hojgaard]

Niels, thank you for the questions. We're not guiding on the cash flow, so I cannot give you an exact number. But of course, it's easy to model out based on our guidance that our overall net cash position for the year is going to be negative. I think you understand all the reasons, and I think I already explained that this is happening in a very controlled manner. This takes us to the second point about the gearing, which is actually smack-on where we have estimated it to be when we exit this quarter here. And I think that reaches back to the answer I gave earlier here that we have clear plans on how we are going to finance our way ahead, not only for this year, but also as we move forward.

[Juan Jose Gonzalez, CEO & Member of Executive Board]

Yes. Niels, I mean -- and this is maybe just for the overall group. We basically have a very clear strategy. Our strategy is to maximize our first-mover advantage by introducing superior innovation at scale across multiple endoscopy procedures and building our commercial infrastructure very rapidly.We are doing this because we believe it's the most financially attractive way for the company to move forward. We are doing this because we believe that value creation of a company will be maximized by 2025. And everything you're seeing in terms of financial, our position in terms of cash flow, our gearing reflects the strategy and reflects our plans. And therefore, we have already, some time ago, secured all the financing for everything that we need as we move to execute this strategy with significant freedom to operate. So this is actually in line with our plan. This is our -- what you are seeing in terms of our financials is the strategy of the company.

[Niels Granholm-Leth]

That's great. And could I just follow up with one additional question, if I may. When it comes to your strategy as to, what should I say, receive full payment for your monitors among European hospitals, historically, monitors have been used as a way to ramp up new customers. Is this still the case? Or should we expect you to, a much higher extent, actually charge full price for monitors going forward, also considering the high component prices right now?

[Juan Jose Gonzalez, CEO & Member of Executive Board]

Yes. Thank you for the question. I mean, first of all, just to put into context, monitors is less than 2% of our sales. So we're talking about a very small part of our business. Now we are not really changing our commercial practice across U.S., Europe and Asia Pacific. In some cases, the monitor is unsold. In some cases, are part of large contracts to drive penetration of our scopes. But overall, what we have been doing over the last 3 years will continue to be done as we introduce our new products.

[Niels Granholm-Leth]

And that regards with the aBox 2 as well. So this is also a product that will be used to ramp up new customers.

[Juan Jose Gonzalez, CEO & Member of Executive Board]

Yes. Again, in some cases, we sell the product. In some cases, are part of large contracts. At the end of the day, 2 things I'm going to -- 2 things are true. One is this will continue to be less than 2% of our sales. Our growth is really driven by scopes, and the financial profile of monitors will remain how it has been in the last 3 years.

[Operator]

The next question is from Craig Mcdowell, JPMorgan.

[Craig Mcdowell, Analyst]

It's Craig Mcdowell from JPMorgan. Most of the questions were covered, but just one question on pricing. You said that your pricing is based on theoretical cost, neutral versus reusable. And I'm wondering, in particular, on duodenoscope, can you comment on what your reps are seeing in the field? Do customers recognize your theory behind your pricing? And how has your experience in pricing of duodenoscope had any impact on the price set for gastro, which I think is a bit lower than what's previously sort of indicated?

[Juan Jose Gonzalez, CEO & Member of Executive Board]

Yes, Frederick (sic) [ Craig ], thank you and excellent questions. First of all, we see our pricing strategy as a major competitive advantage when we introduce our products. And in the case of our Duo 1.5, I think Bassel mentioned, we expect to be the #1 player in duodenoscopy globally, especially outside of the U.S. And I have to say, outside of the U.S., we really don't see much competition. Most of our evaluations are along. They are not even head-to-head competitions because of how important is pricing, how important it is for health care systems to know that they have an option, which is neutral in cost to transition. Now specifically in the case of the U.S., the environment is becoming very favorable to drive the transition from single-use. We went from a special reimbursement in Medicare for outpatient procedures to also have it for inpatient procedures and then to have all major private payers also setting a special reimbursement if hospital use single-use duodenoscope.If I take Medicare for inpatient procedures and private payers, they are setting a level of reimbursement for single-use duodenoscopy, which is higher than our pricing. That basically means that any hospital that decides to go with our aScope Duo will actually get economic incentive from doing it on top of a normal reimbursement they get in duodenoscopy. And as we go on go through the evaluations and do our pro demonstration, that's clear resonating in terms of level of interest for adoption.And by the way, this environment is the same environment we have seen before when there is an incentive for a market to transition from one technology to another. And that's basically what we are expecting.Now the pricing for our gastroscope, I mean, I think duodenoscope is a reference, and there are some learnings on that. But cystoscopy, it's also a reference, and ENT and pulmonology. What we have learned is that what is critical for us is to look at the reusable gastroscopy procedure cost and making sure that our pricing enables a neutral transition. And that's really what is informing our gastro pricing. The combination of what is actually a new benchmark in terms of technology and image resolution with our $350 scope is what will guarantee our ability to penetrate this market.

[Operator]

The next question is from Yiwei Zhou, SEB.

[Yiwei Zhou, Analyst]

I have two. And firstly, a follow-up question on the Mexico plant. So how much production volume can be done in your Mexican plant from the end of this year? And when should we expect the ramp-up cost to normalize in the coming quarter? I'll do one at a time.

[Juan Jose Gonzalez, CEO & Member of Executive Board]

Listen, thank you for the question. I don't think we have provide any capacity numbers regarding our Mexico plant. What we have said though is that this is going to be the largest single-use endoscopy plant. So this plant is projected to be much bigger than our plant in Malaysia. We are starting production this year, and the ramp-up is an accelerated one. But of course, in terms of normalization, in terms of the impact of the cost, will depend on how rapidly our volume growth in that plant, and we are not providing any guidance at this point.

[Yiwei Zhou, Analyst]

Okay. So let me just follow up here. Considering the current transportation challenges, is it fair to assume you would sort of produce more in the Mexico plant than the -- your old plant in Malaysia?

[Juan Jose Gonzalez, CEO & Member of Executive Board]

I mean, the -- so if you look at the medium term, Mexico is projected to produce more than Malaysia. More importantly, Mexico is -- has been built to be able to support the U.S. business. And coming online this year and then scaling up over the next quarters, that basically will allow us to do two things. One is reduce our distribution costs as we don't need to either send by sea or by air freight formation to the U.S. and reduce our levels of inventory. That's why we are so excited in terms of our Mexico plant. This is not just about getting more capacity to support the company growing at 46% volume growth. This is also going to allow us to do it more efficiently.

[Yiwei Zhou, Analyst]

Okay. And my next question is regarding the gastroscope. You mentioned that gastroscopy is performing different hard to the units. So could you comment a bit on the -- which units will you talk initially? And when do you expect the uptake to accelerate?And maybe if allow, could you also elaborate a bit on the -- one of the features you mentioned on the product catalog for gastroscope. Here, I realized there is sort of a feature, which we don't see for other scopes. That's the major enhancements. Could you also comment on this new feature?

[Bassel Rifai, SVP & Chief Marketing Officer]

Sure. I'm happy to take those questions. So first of all, in terms of the hospital units, I think what I shared earlier is the total effect of operating in multiple parts of the hospital is what creates this challenge when it comes to logistics and availability. So our plan actually will be to target different sites of care in the hospital.Now there's going to be some where they're most acutely dealing with this challenge, which is areas like the operating room and the ICU. And for those, it's going to be a very welcome thing where they're usually waiting more for procedures where they can benefit the most from a sterile environment and so forth. So the operating room with bariatric and foregut surgeons is going to be a natural entry point.But I will say that looking more broadly, when we look at the Endo suites, we know there's going to be a huge logistics benefit from handling cases where scopes are broken or unavailable, handling first case of the day, last case of the day, nights and weekends. For sure, there's going to be a big target market there. In terms of the operating room, we can see -- because of the lower volumes they have there but the need for sterility and availability, we can see high opportunities for conversion there. And then, of course, for the intensive care unit and for emergency room where quite often availability -- urgent availability is most critical, we see high opportunities there. So I think all of those will be areas that we target as we move forward with our commercial launch.And then the second thing in terms of image quality or image performance. The most important thing is that with this launch, we're taking the next step in terms of technologies that relate to image performance. That means the camera sensor that's 4x more powerful, image processing unit that's more powerful. And on top of that, we're adding our first image enhancement feature. And that's going to be basically allow doctors and staff to see more clearly vasculature, and that's important in many kind of routine diagnostic procedures. So you can imagine that in the future, we're also going to be introducing more and more features that supports improved image quality and image processing in the coming years. But we come already to the market today with this advanced technology that supports over half of the 20 million gastroscopy procedures worldwide.

[Operator]

There are no further...

[Juan Jose Gonzalez, CEO & Member of Executive Board]

Thank you very much -- all right. Thank you very much, everyone. And I appreciate you guys joining our quarterly call, and we look forward to our next meeting where we'll be talking about the progress of our innovation and our next major launches. Thank you.